1. Technical Field
The present application relates to systems and methods for the safe transportation of medicaments and, more particularly, to systems and methods for the handling and transport of potentially hazardous medicaments, in particular, cytotoxic drugs and the like.
2. Background of Related Art
In one instance, hazardous medicines are frequently applied in the treatment of certain diseases, in particular, for example, in the treatment of cancer. Cytotoxic drugs have generally been used to kill cancer cells. However, the use of cytotoxic drugs, in the treatment of cancer cells, presents specific dangers to all cells, both in the patient and in healthcare providers. Although the exposure to a health care provider is normally very small for each cytotoxic drug dose administration, evidence suggests that chronic, low-dose exposure can produce significant health problems. Accordingly, a system that allows the safe handling of hazardous drugs while significantly reducing and/or eliminating the exposure to providers would be of great benefit.
Drugs are typically supplied in glass or plastic vials that are capped with a gas impermeable liquid seal or stopper. In some instances, the vial contents are a solid powder, such that a liquid needs to be injected for mixing (e.g., reconstitution). The injection of additional contents (e.g., liquid) into the vial produces an increased pressure which stresses the seal or stopper. Although the vial is intended to be sealed to liquid and gases, drug molecules in vapor phase can leak or pass around the sides of the stopper or through the stopper as the injection needle is withdrawn, thus presenting a hazard to the provider or clinician.
Accordingly, with the potential for aerosol leakage, leakage/spraying upon needle withdrawal, or spills, a means with which to prevent the accidental vapor phase drug egress is required. The provision of a pressure gradient/differential across the seals will ensure that any gas will flow from high to low pressure. Establishing a negative relative pressure between the inside of the transfer volume and atmosphere will prohibit the egress of vapor phase drug.
Thus, the need exists for new components and systems capable of transferring gases/fluids/liquids or other substances between a conventional syringe and one of a vial, a patient I.V. (intra-venous) set, or an I.V. bag without leaking or spilling and without exposure of the liquids to substances outside the closed system. As such, healthcare personnel may more safely use and handle fluid substances including potentially hazardous liquids and the like.
The hazardous medicines, including Cytotoxic drugs amongst others, are typically prepared by a technician in a clean room setting, or by a fully automated or robotic system. However, it is desirable to provide a system for the preparation of these hazardous medicines that is semi-automated or that is a user/technician assisted system, wherein some portion or steps in the preparation of these hazardous medicines is accomplished by the user/technician and some portion in the preparation of these hazardous medicines is accomplished by an apparatus or the like.
Additionally, these hazardous medicines must be prepared in a clean room setting or the like, such as, for example, in a room, under a hood, in a chamber, or the like. A clean room is a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Clean rooms are classified by the cleanliness of their air. Accordingly, for the preparation of these hazardous medicines, it is required that the clean room have an ISO (International Standards Organization) class 5 rating.
Clean rooms are designed to maintain positive air pressure, preventing “unclean” (contaminated) air from flowing inside and less-clean air from flowing into clean areas. The idea is to ensure that filtered air always flows from cleanest to less-clean spaces.
ISO class 5 and cleaner facilities rely on unidirectional, or laminar, airflow. Laminar airflow means that filtered air is uniformly supplied in one direction (at a fixed velocity) in parallel streams, usually vertically. Air is generally re-circulated from the base of the walls of the clean room back up to the filtering system.
Thus, a critical factor in clean room design is controlling air-change per hour (ACH), also known as the air-change rate, or ACR. This refers to the number of times each hour that filtered outside air replaces the existing volume in a building or chamber.
Further, another critical factor in clean room design controlling or reducing the turbulence of the air flowing through the clean room, wherein lower turbulence will increase the cleanliness of the room.
In ISO class 5 clean rooms, the particle per cubic meter must be no more than 3520 particles/m3 in a size of 0.5 micrometers or larger when counted at representative locations normally not more than 1 foot away from the work site, within the airflow, and during filling/closing operations.
Accordingly, improvements in systems for the handling and transport of potentially hazardous medicines, in particular, cytotoxic drugs and the like, in a clean room or chamber, is desired and warranted.